Lipedema Subcutaneous Fat
Conditions
Interventions
A randomized, controlled, double-blind clinical trial will be conducted at the Laboratory of the Study Group in Dermatofunctional Physical Therapy, Department of Physical Therapy, Federal University o
and the Sham Shockwave Therapy Group (GSHAM), which will receive simulated shockwave therapy combined with MLD. To ensure blinding, all participants will wear noise-canceling earmuffs during the sessi
0.11 mJ/mm²) at a frequency of 20 Hz, totaling 5,000 pulses per lower limb (3,500 per thigh and 1,500 per leg), using a 34-mm applicator tip. In the sham group, the “start” button will not be activate
the procedure will be simulated using a speaker reproducing the characteristic sound of the device. Randomization will be performed at a 1:1 ratio using a computer-generated sequence created at www.ra
Sponsors
Universidade Federal da Paraíba
Universidade Federal da Paraíba
Eligibility
Sex/Gender
Female
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Women; with early-stage lipedema (stage I/II) affecting the lower limbs (types 2, 3, and 5); aged over 18 years; presenting pain greater than three (3) on the Numeric Rating Scale (NRS); who have not undergone previous surgery for lipedema; without skin lesions or pacemakers; not using medications for lipedema-related symptoms, such as pain or edema, within 48 hours prior to the intervention; not undergoing other treatments for lipedema; and who agree to participate in the study by signing the Informed Consent Form (ICF)
Exclusion criteria
Exclusion criteria: Presence of a pacemaker; coagulation disorders; use of anticoagulant medications; history of neoplasia; pregnancy; soft tissue wound infection; osteomyelitis; presence of an adverse reaction
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| A reduction in pain intensity is expected, as assessed by the Numeric Rating Scale (NRS) and the Brief Pain Inventory (BPI). The NRS consists of a linear scale ranging from 0 to 10 points, on which participants rate their pain according to the numerical values displayed. The absence of pain corresponds to 0, whereas the worst pain ever experienced corresponds to 10. A reduction in pain will be defined as a minimum difference of 1.6 points between pre- and post-intervention measurements. The BPI assesses pain intensity and its interference with activities of daily living using a numeric scale from 0 to 10, with higher scores indicating greater pain intensity and greater interference.;A reduction in lower limb edema is expected following the intervention, as assessed by leg circumference measurements. The apex of the patella will be used as the anatomical reference point, with measurements obtained at 7-centimeter intervals. | — |
Secondary
| Measure | Time frame |
|---|---|
| An improvement in lower limb functional capacity is expected, as measured by the Timed Up and Go (TUG) test, which assesses the time required to stand up from a chair, walk 3 meters to a marker, walk around the marker, return to the chair, and sit down.;An improvement in quality of life among women is expected, as measured by the SF-36 and the Lymphedema Quality of Life (LYMQOL) questionnaires. The SF-36 consists of eight domains: physical functioning, role limitations due to physical health, pain, general health status, vitality, social functioning, role limitations due to emotional problems, and mental health. Scores range from 0 to 100, with higher values indicating better overall health status. The LYMQOL assesses lymphedema-related quality of life by calculating the mean score for each domain (function, appearance, symptoms, and mood), with higher values representing poorer quality of life.;A reduction in lipedema symptoms is expected, as assessed by the Lipedema Symptom Assessment Questionnaire (QuASil). The questionnaire consists of 10 items scored from 0 to 10, with higher scores indicating more severe symptoms. | — |
Countries
BR
Contacts
Public ContactAndreza Rocha
Universidade Federal da Paraíba
Outcome results
None listed